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510(k) Data Aggregation
K Number
K021098Device Name
DAUM-LECTRIC MRI DRILLING MACHINE
Manufacturer
Date Cleared
2002-12-03
(243 days)
Product Code
Regulation Number
874.4250Why did this record match?
Applicant Name (Manufacturer) :
MRI DEVICES DAUM GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Daum p-lectric Drilling Machine is a piezoelectrically driven hand held drill intended to assist the surgeon to access bony tissue. The Daum p-lectric Drilling Machine can drill into hard and soft bone tissue to create a small hole or to obtain bony tissue samples. The Daum p-lectric Drilling Machine is designed to be used inside or close to an MRI Unit up to 1.5 Tesla.
Device Description
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K Number
K010037Device Name
DAUM DOUBLE-SHOOT BISOPSY GUN
Manufacturer
Date Cleared
2001-03-22
(77 days)
Product Code
Regulation Number
876.1075Why did this record match?
Applicant Name (Manufacturer) :
DAUM GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K991366Device Name
DAUM MRI/CONVENTIONAL BIOPSY KIT
Manufacturer
Date Cleared
1999-06-25
(66 days)
Product Code
Regulation Number
876.1075Why did this record match?
Applicant Name (Manufacturer) :
DAUM GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Dasm MRI/Conventional Biopsy Set consists of two parts, the Daum BiopsyGun and the Daum CoaxNeedle. The BiopsyGun is used for automatic biopsy of soft tissues, and the CoaxNeedle is intended for use in open and percutaneous surgical procedures of the brain. The patented surface treatment of the needle optimizes its use in the MRI setting, producing a low-artifact visualization of the needle,
Device Description
The Dasm MRI/Conventional Biopsy Set consists of two parts, the Daum BiopsyGun and the Daum CoaxNeedle. The BiopsyGun is used for automatic biopsy of soft tissues, and the CoaxNeedle is intended for use in open and percutaneous surgical procedures of the brain. The patented surface treatment of the needle optimizes its use in the MRI setting, producing a low-artifact visualization of the needle,
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K Number
K990782Device Name
DAUM NEUROGATE TROCAR
Manufacturer
Date Cleared
1999-04-28
(50 days)
Product Code
Regulation Number
876.1075Why did this record match?
Applicant Name (Manufacturer) :
DAUM GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Daum NeuroGate Trocar is a reusable surgical instrument made of titanium, which is to be inserted into the skull. The insertion is done with the aid of an insertion tool. This trocar function is for inserting and fixing of needles and instruments. NeuroGate trocar is available with several channel diameters (I IG, 14G, 16G) allowing a combination with all Daum neuro needles.
Device Description
The Daum NeuroGate Trocar is a reusable surgical instrument made of titanium, which is to be inserted into the skull. The insertion is done with the aid of an insertion tool. This trocar function is for inserting and fixing of needles and instruments. NeuroGate trocar is available with several channel diameters (I IG, 14G, 16G) allowing a combination with all Daum neuro needles.
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K Number
K970037Device Name
TARGOGRID
Manufacturer
Date Cleared
1997-03-12
(65 days)
Product Code
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
DAUM GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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